New Formulation of Cyclophosphamide Approved
On July 3, 2023, Nevakar Injectables received U.S. Food and Drug Administration (FDA) approval for a new formulation of cyclophosphamide ready-to-dilute (RTD). It is a synthetic antineoplastic drug chemically related to nitrogen mustards. Cyclophosphamide is an alkylating agent used to treat many forms of cancer including acute lymphocytic leukemia (ALL), breast cancer, Hodgkin’s and Non-Hodgkin’s lymphoma (including Burkitt’s lymphoma), cutaneous T-cell lymphoma (including mycosis fungoides), chronic lymphocytic leukemia (CLL), multiple myeloma, ovarian cancer, retinoblastoma, acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML) and neuroblastoma. It is also used to treat patients who have minimal change nephrotic syndrome and who have failed to respond to or could not tolerate corticosteroid treatment. The new RTD formulation will be available in two strengths, 500mg/2.5mL and 1 gram/5mL vials with no preservatives. The product does not need to be reconstituted before dilution, which provides convenience to healthcare providers while eliminating waste, exposure to the product, and potential dosing errors. Cyclophosphamide has been approved in the U.S. since 1959 and it is also available as a lyophilized injection, powder for injection, solution for injection, oral capsule, and oral tablet. The launch date and pricing have not been announced.
More Biosimilars to Humira Available
Under settlement agreements with AbbVie, several biosimilars to Humira® (adalimumab) are now available in the U.S. market. All of them are approved for treating the same major inflammatory conditions as Humira, including adult ankylosing spondylitis, plaque psoriasis, psoriatic arthritis (PsA), rheumatoid arthritis (RA) and ulcerative colitis (UC); as well as pediatric and adult Crohn’s disease and polyarticular juvenile idiopathic arthritis (pJIA). In addition, the prescribing information for the majority of biosimilars to Humira also lists the treatment of adults who have hidradenitis suppurativa. Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm) is the only one that currently includes the treatment of adults who have uveitis. As with all drugs that block the activity of tumor necrosis factor (TNF), biosimilars for Humira carry boxed warnings outlining the increased risks of cancer and serious infections that may be associated with their use. Prospective patients also should be screened for tuberculosis (TB) before starting treatment and periodically while therapy continues.
Pediatric Indication for Nucynta Oral Solution and Tablets
The FDA extended its approval of Collegium Pharmaceuticals’ Nucynta® (tapentadol oral solution and tablets) CII to pediatric patients on July 3, 2023. Now indicated to treat children at least six years old, the opioid is used for the continual treatment of severe pain that has not been relieved by other therapies. For pediatric patients, doses depend on body weight with an upper daily limit of 7.5mg/kg. Typically, doses are given once every four hours for the shortest amount of time and at the lowest dose that provides adequate pain management. As with all opioids, Nucynta has a boxed warning and a Risk Evaluation and Mitigation Strategy (REMS) that inform prescribers and patients about its potential for abuse, misuse, overdose, and addiction. Patients and their caregivers should be aware of the signs of overdoses. Prescribers should consider prescribing naloxone and training caregivers on how to use it to reverse an overdose. The immediate-release formulations of Nucynta have been on the U.S. market since 2008 for the relief of moderate-to-severe acute pain for adults who need continuous, around-the-clock opioid analgesia. The extended-release form, Nucynta® ER tablets is not approved for pediatric use. Revised prescribing information for Nucynta oral solution is here; for tablets, here.